[Type here] Version Approval Dates Announcement Date Effective Standards Committee: Jan 2019

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1 SECTION D AUTHORIZATION, INFORMED CONSENT, DONOR SCREENING, AND TISSUE RECOVERY, COLLECTION, AND ACQUISITION D1.000 GENERAL POLICIES In addition to the requirements at the series of standards at B1.500, all referral arrangements with organ procurement organizations, donor referral sources and other tissue banks shall be documented. (LD) Except for a reproductive tissue bank, written procedures for interacting with operating room staff, the patient s physician, or other sources/facilities shall be established. D1.100 Monetary Compensation or Other Valuable Consideration Monetary compensation or other valuable consideration, including goods or services, shall not be offered to a donor, authorizing person, the donor s estate, or any other third party acting on behalf of the donor, except in the following instances: 1) the tissue bank may reimburse responsible third parties for costs directly associated with a donation; or 2) the tissue bank may reimburse living donors for costs associated with an acceptable donation, including compensation for restoration of lost earnings when directly attributable to donation, if and as authorized by law. (R) The reproductive tissue bank may provide monetary compensation to donors of reproductive tissue if the compensation is compliant with professional standards of practice. Donors or their families should not be responsible for any expenses related to the recovery of allogeneic tissue. D1.200 Tissue for Research Facilities providing tissue for research and other non-transplantation purposes shall develop detailed relevant specific policies and procedures. Informed consent or authorization for research and/or education shall be obtained. See the series of standards at D2.000 and D D1.210 Written Requests All requests for human tissue intended for research use shall be submitted in writing. The request shall indicate the type of tissue requested and how it will be used as well as the name, address and affiliation of the principal investigator accepting responsibility for receipt of the tissue. D1.220 Review and Approval Tissue requests for research purposes shall be reviewed and approved based on legal, ethical, and technical considerations defined in the SOPM.

2 D1.300 Consideration for the Donor (Effective March 3, 2018) A policy shall be established requiring the donor always be treated with dignity and respect. D2.000 AUTHORIZATION D2.100 Requirements Authorization to acquire tissues and make them available for transplantation, therapy, research or education shall be obtained from a donor or authorizing person in accordance with applicable anatomical gift acts and other laws or regulations. This authorization shall be expressed in a document of gift/authorization, the original or a copy of which shall be maintained in the donor s record at the tissue bank responsible for recovery, as well as in the donor s record at the tissue bank whose Medical Director is responsible for the donor eligibility determination. In the case of an electronic or voice recorded document of gift/authorization, the original recording should be maintained in reproducible form. NOTE: For international members, terminology used by the government/competent authority having jurisdiction applies regarding lawful authorization for donation of tissues for transplantation, therapy, research, or education. D2.200 Conditions Adequate information concerning the donation and recovery of tissue shall be presented in a language in which the authorizing person is conversant and in terms that are easily understandable by the authorizing person. The donation coordinator should be trained to appropriately answer the questions the authorizing person may have. Neither coercion nor inaccurate information shall be used in any manner to obtain authorization. D2.300 Signatures and Documentation D2.310 Document of Gift In cases where a donor has executed a document of gift it may be acted upon (permits recovery) provided it meets applicable laws and regulations. Acceptable documentation may include a state driver s license, living will, advanced directive, state ID card, donor card, or photocopy thereof, and documentation that the donor registered in a donor registry. D2.320 Document of Authorization When a document of authorization is used it must contain the following signatures and related information: 1) the authorizing person s signature and: a) name;

3 b) mailing address (NOTE: If requested by the authorizing person, only an address may be documented as the address but, in such cases, the authorizing person should permit its use and should be informed that if the address changes or if communication is blocked, there may be no effective forwarding or receipt of information.); c) phone number; and d) relationship to the donor; 2) the donation coordinator s signature and: a) the date; and b) identity of their organization; 3) the signature of each witness if witnessing is required by law or regulation; 4) documentation that the Core Elements were used; and 5) a statement granting authorization for tissue recovery. D2.330 Methods of Obtaining Authorization Legal authorization can be obtained using different methods. When authorization is obtained: 1) in person, the authorizing person must read and sign the document of authorization. 2) by telephone, the person obtaining the authorization shall read to the authorizing person the document of authorization or, alternatively, shall present each of the Core Elements described in D This telephone conversation shall be recorded. There shall be documentation that the authorization was obtained by telephone. A sampling plan must be adopted that verifies that recordings match the content in the written document of authorization. This verification must be performed by someone other than the donation coordinator or witness. In the rare event that the telephone conversation cannot be recorded (e.g., equipment failure), and no facsimile or electronic means is feasible for documenting authorization, the conversation should be witnessed by a third person. Sampling plans and methods must be established, must be adequate for their intended use, and must be based on valid statistical rationale (e.g., such as the FDA Guide to Inspection of Quality Systems). 3) using a facsimile transmission, a copy of the document of authorization is provided to the authorizing person. The authorizing person shall return the signed

4 document of authorization by facsimile transmission. A donation coordinator shall be available to respond to questions posed by the authorizing person. A sampling plan must be adopted that verifies signatures received by facsimile. This verification must be performed by someone other than the donation coordinator or witness. Sampling plans and methods must be established, must be adequate for their intended use, and must be based on valid statistical rationale (e.g., such as the FDA Guide to Inspection of Quality Systems). 4) using an electronic transmission, a copy of the document of authorization is provided to the authorizing person. The authorizing person shall electronically respond (e.g., by ) that he/she has read the document of authorization, is authorized to grant authorization, and is granting such authorization. A donation coordinator shall be available to respond to questions posed by the authorizing person. A document of authorization received by electronic transmission should be verified pursuant to the relevant law on electronic signatures, such as the Uniform Electronic Transactions Act of the relevant state. An electronically transmitted, read-only or otherwise protected document of authorization may be used. D2.400 Core Elements for Authorization The document of authorization shall contain adequate information. No document of authorization from an authorizing person shall be acted upon if it does not contain the following Core Elements. These Core Elements also apply to D Core Elements: 1) the name of the Donor; 2) the name, mailing address, and telephone number of the authorizing person, and his/her relationship to the donor (NOTE: If requested by the authorizing person, only an address may be documented as the address but, in such cases, the authorizing person should permit its use and should be informed that if the address changes or if communication is blocked, there may be no effective forwarding or receipt of information.); 3) an explanation that the tissue is a gift, and that neither the donor s estate nor the authorizing person will receive monetary compensation or valuable consideration for it; 4) a description of the general types of tissue to be recovered; 5) a description of the permitted use(s) of the recovered tissues (i.e., transplant, therapy, research, or education); 6) an explanation that recovery of tissue requires the following actions, and the document of gift/authorization thus specifically authorizes:

5 a) access to, and required disclosure of, the Donor s medical and other relevant records; b) testing and reporting for transmissible diseases; c) the removal of specimens which may include, but are not limited to blood or tissue samples for the purposes of biopsy or other testing necessary for determination of donor eligibility; d) the release to the tissue bank of any and all records and reports of a Medical Examiner, Coroner or Pathologist (e.g., autopsy report); and e) such other requirements as may be applicable for the specific donation or tissue bank, such as transport of the donor s body, archiving of samples, photographic or other imaging, etc. 7) contact information for the organization represented by the donation coordinator; and 8) any additional information required by laws or regulations. The following information should be provided to an authorizing person: 1) a general description of the recovery e.g., timing, relocation of donor if applicable, contact information, etc.; 2) an explanation that costs directly related to the evaluation, recovery, preservation, and placement of the tissues will not be charged to the family; 3) an explanation regarding the impact the donation process may have on burial arrangements and on appearance of the donor s body; and 4) an explanation that the document of authorization is available. Any explanation required by law, such as an explanation that multiple organizations (nonprofit and/or for profit) may be involved in facilitating the gift(s) and/or reference to the possibility that tissue may be distributed internationally, must be included. When an Organ Procurement Organization (OPO), or other entity (e.g., hospital), has initiated the process of obtaining authorization for a potential organ and tissue donation, the tissue bank for which the authorization is being obtained shall request that the OPO or other entity follow the procedure and utilize a document of authorization that satisfies the requirements of D For a donor one month (28 days) of age or less, adequate consent pursuant to law shall be obtained for collection of blood from the birth mother that will be used for testing. D2.500 Notification of Gift In cases where the gift is authorized by a donor s own document of gift (i.e., first person

6 consent), including a document of gift recorded in a donor registry (i.e., donor designation), and where law mandates notification, such notification shall be made pursuant to law. In all other cases, prior to transport of the donor s body or recovery, the donation coordinator should attempt to notify the person who would have been an authorizing person had no gift been made during the life of the donor or the person who is authorized to make arrangements for final disposition. The information to be provided in the notification should contain, at a minimum, Core Elements of authorization but at no time shall the donation coordinator indicate that the recipient of the information is empowered to revoke or amend the gift made by the donor. The donation coordinator should inquire during the notification whether the notified person is aware of any revocation or refusal made by the donor. Notification, if made, shall be documented. Where good faith efforts to notify an appropriate person of the gift fail to result in actual notification within a time frame compatible with the successful recovery of the tissue, the attempt to notify shall be documented, and recovery may proceed. D2.600 Services to Donor Families Services to donor families or referral to a support system must be offered to the authorizing person. Subsequent communications and periodic evaluation of services shall be documented, maintained, and readily available. See AATB Guidance Document No. 4. D3.000 INFORMED CONSENT D3.100 Requirements Except for autologous tissue, informed consent to acquire tissues and make them available for transplantation, therapy, research or education shall be obtained from a living donor or their legal representative, or from a client depositor in accordance with applicable laws or regulations. This informed consent shall be documented in a record of informed consent, the original or a copy of which shall be maintained in the donor s or client depositor s record at the tissue bank responsible for recovery, collection or acquisition, as well as in the donor s record at the tissue bank whose Medical Director is responsible for the donor eligibility determination. In the case of an electronic or voice recorded record of informed consent, the original recording should be maintained in reproducible form. NOTE: For international members, terminology used by the government/competent authority having jurisdiction applies regarding lawful informed consent for donation of tissues for transplantation, therapy, research, or education. (last amended April 19, 2017 D3.200 Conditions Adequate information concerning the recovery, collection, or acquisition of tissue shall be presented in a language in which the living donor or their legal representative, or the client depositor is conversant, and in terms that are easily understandable by them. The donation coordinator should be trained to appropriately answer the questions the living donor, their legal

7 representative, or the client depositor may have. Neither coercion nor inaccurate information shall be used in any manner to obtain informed consent. The potential donor or their legal representative shall not be under the influence of anesthesia or any drug that could influence his/her ability to give informed consent. Informed consent must be obtained prior to recovery or acquisition, or when not possible and recovery or acquisition has already occurred, as soon as practical before use of the tissue. D3.300 Signatures and Documentation The record of informed consent must comply with applicable laws and regulations. It must contain, at a minimum, 1) the living donor s signature or their legal representative s signature, or the client depositor s signature and: a) name; b) mailing address (NOTE: If requested by the living donor, their legal representative, or the client depositor, only an address may be documented as the address but, in such cases, the living donor, their legal representative, or the client depositor should permit its use and should be informed that if the address changes or if communication is blocked, there may be no effective forwarding or receipt of information.); c) phone number; 2) the donation coordinator s signature and: a) the date; and b) identity of their organization; 3) the signature of each witness if witnessing is required by law or regulation; 4) documentation that the Core Elements for informed consent (see D3.400) were used; 5) a statement that the living donor or their legal representative, or the client depositor understands what has been read or explained and is granting informed consent for tissue recovery, collection, or acquisition; and 6) a statement that the living donor or their legal representative, or the client depositor has been informed that his/her name and address, as well as required records, shall be kept on file by the tissue bank or reproductive tissue bank. D3.310 Methods of Obtaining Informed Consent Informed consent can be obtained using different methods, if and as authorized by law or regulation. The methods below appear in preferential order. When informed consent

8 is obtained: 1) in person, the living donor, their legal representative, or the client depositor must read and sign the record of informed consent. 2) by telephone, the person obtaining the informed consent shall read to the living donor, their legal representative, or the client depositor the record of informed consent or, alternatively, shall present each of the Core Elements described at D This telephone conversation shall be recorded and it shall be documented that the informed consent was obtained by telephone. A sampling plan must be adopted that verifies that recordings match the content in the written record of informed consent. This verification must be performed by someone other than the donation coordinator or witness. In the rare event that the telephone conversation cannot be recorded (e.g., equipment failure), and no facsimile or electronic means are feasible for documenting informed consent, the informed consent may be made telephonically and should be witnessed by a third person. Sampling plans and methods must be established, must be adequate for their intended use, and must be based on valid statistical rationale (e.g., such as the FDA Guide to Inspection of Quality Systems). 3) using a facsimile transmission, a copy of the record of informed consent is provided to the living donor, their legal representative, or the client depositor. The living donor, their legal representative, or the client depositor shall return the signed record of informed consent by facsimile transmission. A donation coordinator shall be available to respond to questions posed by the living donor, their legal representative, or the client depositor. A sampling plan must be adopted that verifies signatures received by facsimile. This verification must be performed by someone other than the donation coordinator or witness. Sampling plans and methods must be established, must be adequate for their intended use, and must be based on valid statistical rationale (e.g., such as the FDA Guide to Inspection of Quality Systems). 4) using an electronic transmission, a copy of the record of informed consent is provided to the living donor, their legal representative, or the client depositor. The living donor, their legal representative, or the client depositor shall electronically respond (e.g., by ) that he/she has read the record of informed consent, and is granting such informed consent. A donation coordinator shall be available to respond to questions posed. A record of informed consent received by electronic transmission should be verified pursuant to the relevant law on electronic signatures, such as the Uniform Electronic Transactions Act, of the relevant state. An electronically transmitted, read-only or otherwise protected record of informed consent may be used. D3.400 Core Elements for Informed Consent

9 No informed consent from a living donor, their legal representative, or a client depositor shall be acted upon if it does not contain the following Core Elements. Core Elements: 1) the name of the living donor or client depositor; or 2) the identity of the person authorized by law to consent on behalf of the living donor or client depositor and his/her relationship to the subject including name, address, and telephone number; 3) if applicable, an explanation that the tissue is a gift, and that the living donor or their legal representative will not receive monetary compensation or valuable consideration for it; 4) a description of the general types of tissue to be recovered, collected, or acquired and any information pertinent to the specific recovery, collection, or acquisition contemplated; 5) a description of the permitted use(s) of the tissues (i.e., transplant, therapy, research, or education); 6) a description of the general purposes for which the tissue may be used; 7) a legally adequate release of the relevant medical records of the living donor, their legal representative (when applicable), or of the client; 8) permission to test for disease, if applicable; 9) a statement that confirmed positive test results will be reported or disclosed if required by law or regulation (e.g., to the living donor, their legal representative, or the client depositor, to the attending physician, to appropriate health officials); 10) contact information for the organization represented by the donation coordinator; 11) information concerning possible risks and benefits to the living donor, their legal representative, or the client depositor, if applicable; and 12) any additional information required by laws or regulations. Any explanation required by law, such as an explanation that multiple organizations (nonprofit and/or for profit) may be involved in facilitating the gift(s) and/or reference to the possibility that tissue may be distributed internationally, must be included. (R) In the case of a client depositor the record of informed consent shall also include details about costs of tissue cryopreservation, storage, distribution and disposition options. In the case of an anonymous donor, the record of informed consent shall also include details about monetary compensation. See D1.100.

10 D3.500 Services Involving Living Donors (BT) Services shall be developed that provide answers to questions posed by the birth mother after delivery. D4.000 DONOR SCREENING AND TESTING Current (14 th Edition) D4.100 Donor Screening Donor eligibility criteria shall be established by the Medical Director and shall not conflict with these Standards. Each donor shall be evaluated according to established criteria. (A) (BT) Donor eligibility shall be documented by a physician caring for the autologous donor. It is not necessary to document a physical examination, a donor risk assessment interview, or medical history and medical record review for autologous tissue in the tissue bank records. Except for autologous donations, the health status of the infant(s) shall be assessed in regard to information that could affect the quality or safety of the tissue for transplantation. Protocols shall be established for reviewing information at the time of the infant s delivery. Policies and procedures should be developed to handle information regarding the health status of the infant reported voluntarily after delivery. Written procedures must describe how information is evaluated. (C) (LD) (R) (S) Heart donors shall also be evaluated for the risk of Chagas disease. Criteria for accepting living donors shall be established by the Medical Director or licensed physician designee. Criteria for accepting client depositors and potential reproductive tissue donors shall be established by the Medical Director or licensed physician designee. Potential donors shall be evaluated on an individual basis by chart review and visual assessment for size, current medical status, and skin condition. With amendments D4.100 Donor Screening Donor screening and donor testing procedures shall be established under the supervision of a contracted licensed physician possessing the qualifications outlined in B Donor eligibility criteria shall be established by the Medical Director of the tissue establishment responsible for the determination of donor eligibility (ref. Section ) and shall not conflict with these Standards. Each donor shall be evaluated according to established criteria. If donor screening and testing is under the supervision of a Medical Director other than the Medical Director responsible for final donor eligibility determination, the former shall be available upon request from the latter to provide clarification about results of donor screening and testing if needed.

11 (A) Donor eligibility shall be documented by a physician caring for the autologous donor. It is not necessary to document a physical examination, a donor risk assessment interview, or medical history and medical record review for autologous tissue in the tissue bank records. (BT) Except for autologous donations, the health status of the infant(s) shall be assessed in regard to information that could affect the quality or safety of the tissue for transplantation. Protocols shall be established for reviewing information at the time of the infant s delivery. Policies and procedures should be developed to handle information regarding the health status of the infant reported voluntarily after delivery. Written procedures must describe how information is evaluated. (C) (LD) (R) (S) Heart donors shall also be evaluated for the risk of Chagas disease. Criteria for accepting living donors shall be established by the Medical Director or licensed physician designee. Criteria for accepting client depositors and potential reproductive tissue donors shall be established by the Medical Director or licensed physician designee. Potential donors shall be evaluated on an individual basis by chart review and visual assessment for size, current medical status, and skin condition. As amended D4.100 Donor Screening Donor screening and donor testing procedures shall be established under the supervision of a contracted licensed physician possessing the qualifications outlined in B Donor eligibility criteria shall be established by the Medical Director of the tissue establishment responsible for the determination of donor eligibility (ref. Section ) and shall not conflict with these Standards. Each donor shall be evaluated according to established criteria. If donor screening and testing is under the supervision of a Medical Director other than the Medical Director responsible for final donor eligibility determination, the former shall be available upon request from the latter to provide clarification about results of donor screening and testing if needed. (A) Donor eligibility shall be documented by a physician caring for the autologous donor. It is not necessary to document a physical examination, a donor risk assessment interview, or medical history and medical record review for autologous tissue in the tissue bank records. (BT) Except for autologous donations, the health status of the infant(s) shall be assessed in regard to information that could affect the quality or safety of the tissue for transplantation. Protocols shall be established for reviewing information at the time of the infant s delivery. Policies and procedures should be developed to handle information regarding the health status of the infant reported voluntarily after delivery. Written procedures must describe how information is evaluated. (C) Heart donors shall also be evaluated for the risk of Chagas disease.

12 (LD) (R) (S) Criteria for accepting living donors shall be established by the Medical Director or licensed physician designee. Criteria for accepting client depositors and potential reproductive tissue donors shall be established by the Medical Director or licensed physician designee. Potential donors shall be evaluated on an individual basis by chart review and visual assessment for size, current medical status, and skin condition. Announcement date: January 31, 2019 (Bulletin 19-1) Effective date: July 31, 2019 (6-month implementation period) D4.110 Age Criteria The Medical Director and/or tissue bank Medical Advisory Committee shall determine donor age criteria. (A) (BT) (R) There are no age limits for autologous tissue donation. There is no age limit for the birth mother, however, policies and procedures shall be written regarding gestational age limits. Semen donors shall be younger than 40 years of age to minimize the risk of genetic anomalies except with the written agreement of the user physician. Oocyte donors shall be younger than 35 years, unless an exception has been made by the Medical Director with documented agreement of the user physician. D4.120 Physical Assessment Prior to the recovery of tissue from a deceased donor, a physical assessment shall be performed by a responsible person. This shall be a recent ante-mortem or postmortem physical assessment to identify evidence of: high risk behavior and signs of HIV infection or hepatitis infection; other viral or bacterial infections; or, signs of trauma or infection to the body where recovery of tissue is planned. If any of the following signs are observed or noted in any other available record, and are deemed to be an indication of these risks, then the tissue shall be rejected: Note: Each risk type is followed by observational wording in parentheses suggestive of terminology that correlates with each listing. See Appendix III. 1) physical evidence for risk of sexually transmitted diseases such as genital ulcerative disease, herpes simplex, chancroid (genital lesions); 2) physical evidence for risk of, or evidence of, syphilis (genital lesions, rash, skin lesion [non-genital]); 3) for a male donor, physical evidence consistent with anal intercourse including

13 perianal condyloma (insertion trauma, perianal lesions); 4) physical evidence of non-medical percutaneous drug use such as needle tracks (and/or non-medical injection sites), including examination of tattoos (which may be covering needle tracks); 5) disseminated lymphadenopathy (enlarged lymph nodes); 6) unexplained oral thrush (white spots in the mouth); 7) blue or purple spots consistent with Kaposi s sarcoma (blue/purple [gray/black] spots/lesions); 8) physical evidence of recent tattooing, ear piercing, or body piercing (tattoos/piercings should be described); 9) unexplained jaundice, hepatomegaly, or icterus. Note: Hepatomegaly may not be apparent in a physical assessment unless an autopsy is performed (enlarged liver, jaundice, icterus); 10) physical evidence of sepsis, such as unexplained generalized rash/generalized petechiae, or fever (rash); 11) large scab consistent with recent smallpox immunization (scab); 12) eczema vaccinatum (lesion, scab); 13) generalized vesicular rash, generalized vaccinia (rash); 14) severely necrotic lesion consistent with vaccinia necrosum (lesion); and/or 15) corneal scarring consistent with vaccinial keratitis (abnormal ocular finding, scarring). The form and instructions in Appendix III must be used to document the tissue donor physical assessment. (S) The physical assessment shall include documentation of findings and conditions that may affect the quality or quantity of skin recovered. D4.130 Physical Examination (LD) Except for autologous and embryo donations, prior to the donation of tissue from a potential living donor, a physical examination shall be performed by the Medical Director or licensed physician designee, or by a physician involved with the individual s medical care, or designee as permitted by law. If an examination of a living donor was performed for other reasons, review of the findings of such an examination shall be performed and documented in the donor s record, as well as all other examination findings. After a donor

14 risk assessment interview is completed, if any history is suspect, a directed physical examination shall be performed. The directed examination shall include any of the above applicable items (see D4.120) that would assist with information to determine whether there is evidence of high risk behavior. (BT) (R) In addition to the (LD) standard above, a physical examination of the birth mother must be performed during admission for delivery or within 14 days prior to delivery. A physical examination must be performed on all anonymous and directed semen and oocyte donors. A repeat physical examination shall be performed on anonymous semen donors at least every 6 months (180 days) while the donor is actively collecting samples in the program. Semen donors shall not exhibit an infectious skin disease that creates a risk of contamination of the semen. D4.140 Donor Risk Assessment Interview (DRAI) A documented dialogue shall be conducted with the donor (if living) or the deceased donor s next of kin, the nearest available relative, a member of the donor s household, other individual with an affinity relationship (caretaker, friend, significant life partner) and/or the primary treating physician, using a standardized questionnaire. Questions shall be formulated using these Standards, current federal regulations and guidance. Questions shall be included that evaluate past medical history for conditions that could constitute a contraindication to the release of tissue for transplantation (e.g., certain infectious diseases, malignancies, and degenerative neurologic disorders), as defined in these Standards (see Appendix II). For all donors one month (28 days) of age or less, the infant and the birth mother shall be screened for risk of relevant communicable disease agents and diseases (RCDADs) and the birth mother s blood must be tested. Refer to D4.100 (BT) for expectations to obtain the health status of the infant donor of birth tissue. The donor risk assessment interview shall document the donor s name, and the relationship between the donor and the interviewee(s) and shall indicate the name(s) of the interviewer(s) and interviewee(s). The questionnaire shall be maintained as part of the donor s record. (A) (BT) The tissue bank shall have a policy for obtaining information from the patient s physician as to whether the autologous donor is at high risk for viral hepatitis or HIV infection. The donor risk assessment interview of the birth mother shall be obtained, or previous donor risk assessment interview information verified, no more than 14 days prior to delivery. If this interview is performed after delivery it must be completed within 14 days of delivery.

15 (LD) (R) Interviews must be administered by trained staff, or if self-administered, a trained staff member must review and verify answers with the donor in order to facilitate comprehension and provision of accurate answers. The donor s risk assessment shall include a review of personal alcohol and drug use and sexually transmissible diseases in the donor and partner(s). The screening process also shall include any history of chemical and/or radiation exposure as well as family medical history and genetic background. An abbreviated donor screening must be obtained at each repeat donation and reviewed by a responsible person. The abbreviated screening must determine and document any changes in the donor s medical, social, travel, and sexual behavior history (including risk factors) since the previous donation that would make the donor ineligible. D4.141 Family History and Genetic Background (BT) (R) If genetic testing has been performed or a genetic history has been obtained and the information is available, it should be considered for the determination of donor eligibility. A minimum of a three-generation family history shall be elicited from each prospective donor. If a biological family member in the prospective donor s family is adopted, Medical Director discretion must be made to determine if sufficient family history is provided to determine donor eligibility. The genetic history should be evaluated by an individual with appropriate clinical genetics education and/or training. Any significant condition in a prospective donor or donor s family history that would pose a risk of producing an offspring with a serious genetic disease or defect greater than the risk in the general population shall disqualify him/her as a donor, with the following exceptions: 1) Anonymous donors whose family history indicates that he/she is at risk for carrying a genetic defect may be accepted only if a test to detect carrier status is performed and is negative for the mutation that is known to occur in the family; or 2) Directed gamete donors and anonymous or directed embryo donors with any family history indicating he/she is at risk for carrying a genetic defect/condition may be accepted, provided the genetic risk to offspring is evaluated in writing and the recipient(s) (R) has reviewed the evaluation, been offered additional genetic testing, and completed an informed consent. If indicated by medical history, family history, or ethnic background, anonymous donors should be screened for Tay- Sachs disease, thalassemia, sickle cell trait, spinal muscular atrophy, and/or cystic fibrosis. D4.150 Relevant Medical Records Review

16 Prior to tissue donation, a preliminary review of readily available relevant medical records shall be conducted by a trained individual. This review shall include but may not be limited to: 1) evidence of significant active infection at the time of donation for relevant communicable disease agents or diseases (RCDADs) including signs and/or symptoms of viral and fungal infection, bacteremia or sepsis; 2) risk factors for relevant communicable disease agents or diseases (RCDADs) as specified in Appendix II; and 3) additional tissue donor specific criteria as documented in the SOPM and compliant with written agreements/contracts. (A) Except for skin, autologous donation should not be undertaken when the autologous donor has, or is being treated for, bacteremia or other significant bacterial infection that can be associated with bacteremia, unless such tissue will be secondarily sterilized prior to transplantation or treated in such a manner to minimize microbial contamination. D4.200 Donor Testing D4.210 Blood Specimens Except as otherwise specified for certain reproductive tissue donors, infectious disease testing of donor blood specimens shall be performed for each tissue donor on a specimen collected at the time of donation or within 7 days prior to or after donation. If the donor is one month (28 days) of age or less, a blood specimen from the birth mother must be collected within 7 days prior to or after tissue donation and tested instead of a specimen from the infant donor. There shall be written procedures for all significant steps in the infectious disease testing process, including blood specimen collection (i.e., documentation of date/time of collection, a donor identifier), documentation of the verification of specimen labeling, and use of appropriate blood specimen types, labels, and instructions for specimen handling. Procedures shall conform to the test kit manufacturer s instructions for use contained in the package inserts. Specimen collection, storage, and handling procedures shall be described in the SOPM. (R) For anonymous and directed oocyte donors, the blood specimen must be collected within 30 days prior to oocyte collection, or within 7 days post donation. Samples for infectious disease testing of anonymous and directed semen donors must be obtained within 7 days of initial semen collection. See D4.360 for testing requirements for embryo donors. D4.211 Plasma Dilution Tissue from a donor who is older than 12 years of age shall be determined to

17 be not suitable for transplantation if blood loss is known or suspected to have occurred and there has been transfusion/infusion of more than 2,000 milliliters (ml) of blood (e.g., whole blood, or red blood cells) or colloids within 48 hours; or more than 2,000 ml of crystalloids within one hour; or any combination thereof, prior to asystole or the collection of a blood specimen, whichever occurred earlier, unless: 1) a pre-transfusion or pre-infusion blood specimen from the tissue donor is available for infectious disease testing; or 2) an algorithm is utilized that evaluates the volumes administered in the 48 hours prior to collecting the blood specimen from the tissue donor to ensure that there has not been plasma dilution sufficient to affect test results. Tissue from a donor who is 12 years of age or less who has been transfused or infused at all, shall be determined to be not suitable for transplantation unless a pre-transfusion or pre-infusion blood specimen from the tissue donor is available for infectious disease testing, or an algorithm is utilized that evaluates the volumes administered in the 48 hours prior to collecting the blood specimen from the tissue donor to ensure that there has not been plasma dilution sufficient to affect test results. When the fluids transfused are in the blood category (alone, or in combination with colloids and/or crystalloids), a comparison of the total volume of these fluids with the donor s estimated blood volume shall be performed, in addition to a comparison of the total volume of colloids and/or crystalloids with the donor s estimated plasma volume. Since every possible clinical situation cannot be described where plasma dilution may affect test results, the SOPM should describe how to address additional circumstances when plasma dilution may have occurred (e.g., large volumes of transfusions/ infusions administered in the absence of blood loss). It may be necessary to use a pretransfusion/infusion blood specimen or apply an algorithm in those instances. Alternative algorithms to evaluate plasma dilution can be used if justified. D4.220 Infectious Disease Testing Results of initial infectious disease and/or confirmatory testing shall be used as one component of determining donor eligibility. Testing used for donor eligibility shall be performed by laboratories that are registered with FDA as a tissue establishment for testing and are either certified to perform such testing on human specimens in accordance with Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. 263a) and 42 CFR part 493, or that have met equivalent requirements as determined by the Centers for Medicare and Medicaid Services. NOTE: For international members that do not export tissues to the U.S., applicable requirements of the government/competent authority having jurisdiction apply regarding establishment registration, laboratory certification, and test kit licensing/approval.

18 FDA-licensed, approved, or cleared donor screening tests must be used, except when testing for Chlamydia or gonorrhea in which case, an FDA-licensed, cleared or approved diagnostic test must be used. A new test shall be implemented when AATB and/or FDA issues notification to that effect. Prior to that time, use of the new test, even if FDA-licensed, approved, or cleared for donor screening, is voluntary. Tests specifically labeled for use with specimens collected after the donor s heart has stopped beating instead of a more generally labeled test shall be used when applicable and when available. * A list of donor screening tests that have been licensed for use with specimens collected after the donor s heart has stopped beating can be accessed at the FDA/CBER website. *See AATB Bulletin No Intent of Update to Standard D (Note: this standard is currently D4.220) Rapid antigen and/or antibody testing for infectious disease may be performed in addition to the required tests. Results of these tests must be evaluated (see F1.140) and shared (see D4.300) in accordance with policies and procedures. If a laboratory that performs organ donor testing performs the initial testing in duplicate or triplicate, the tissue bank must obtain and review the results of all individual tests performed. Individual test results shall be shared in accordance with B1.510, D4.300, and K All tissue from donors who test repeatedly reactive on a required screening test shall be quarantined and shall not be used for transplantation. There shall be written procedures for all significant steps in the infectious disease testing process that shall conform to the manufacturer s instructions for use contained in the package inserts for required tests. These procedures shall be readily available to the personnel in the areas where the procedures are performed unless impractical. The manufacturer s instructions shall be followed in regard to acceptable donor specimens and their handling. Donor sample testing shall be performed, and test results interpreted according to the manufacturer s instructions in the package insert for the particular infectious disease marker. Additional testing to confirm or supplement infectious disease test results may be performed at the discretion of the Medical Director using FDA-licensed, confirmatory test kits when commercially available. Results of infectious disease testing shall be evaluated prior to disclosure of availability of positive test results (see D4.232). Current (14 th Edition) D4.230 Required Infectious Disease Tests Excluding autologous, embryo donor, and client depositor tissue, all human tissue intended for transplantation shall be from donors who are tested and found to be negative for:

19 1) antibodies to the human immunodeficiency virus, type 1 and type 2 (anti- HIV-1 and anti-hiv-2); 2) nucleic acid test (NAT) for HIV-1; 3) hepatitis B surface antigen (HBsAg); 4) nucleic acid test (NAT) for the hepatitis B virus (HBV); 5) total antibodies to hepatitis B core antigen (anti-hbc total, meaning IgG and IgM); 6) antibodies to the hepatitis C virus (anti-hcv); 7) nucleic acid test (NAT) for HCV; and 8) syphilis (a non-treponemal or treponemal-specific assay may be performed). Donors of viable leukocyte-rich tissue (e.g., semen, certain (CT)) shall also be tested and found to be negative for antibodies to human T-lymphotropic virus type I and type II (anti-htlv-i and anti-htlv-ii). Note: HTLV testing of donors of other tissue types may be required by law and/or regulation, including, where applicable, foreign laws and/or regulations. All test results shall be documented in the donor s record. (R) In addition to the infectious disease tests listed above, all anonymous and directed semen and oocyte donors shall undergo testing for Neisseria gonorrhea and Chlamydia trachomatis. The manufacturer s requirements for specimens must be met. If the reproductive tissue is collected by a method that ensures freedom from contamination of the tissue by infectious disease organisms that may be present in the genitourinary tract, then these tests are not required. All anonymous and directed semen donors shall also be tested for total antibody to cytomegalovirus (anti-cmv total, meaning IgG and IgM). Required tests for anonymous and directed embryo donors are listed in D Client depositors who deposit semen, testicular fluid or tissues, oocytes or ovarian tissue, or embryos, shall be tested prior to use for: 1) antibodies to the human immunodeficiency virus, type 1 and type 2 (anti- HIV-1 and anti-hiv-2); 2) hepatitis B surface antigen (HBsAg); and 3) antibodies to hepatitis C virus (anti-hcv). With amendments

20 D4.230 Required Infectious Disease Tests Excluding autologous, embryo donor, and client depositor tissue, all human tissue intended for transplantation shall be from donors who are tested and found to be negative for: 1) antibodies to the human immunodeficiency virus, type 1 and type 2 (anti- HIV-1 and anti-hiv-2); 2) nucleic acid test (NAT) for HIV-1; 3) hepatitis B surface antigen (HBsAg); 4) nucleic acid test (NAT) for the hepatitis B virus (HBV); 5) total antibodies to hepatitis B core antigen (anti-hbc total, meaning IgG and IgM); 6) antibodies to the hepatitis C virus (anti-hcv); 7) nucleic acid test (NAT) for HCV; and 8) syphilis (a non-treponemal or treponemal-specific assay may be performed). Donors of viable leukocyte-rich tissue (e.g., semen, certain (CT)) shall also be tested and found to be negative for antibodies to human T-lymphotropic virus type I and type II (anti-htlv-i and anti-htlv-ii). Note: HTLV testing of donors of other tissue types may be required by law and/or regulation, including, where applicable, foreign laws and/or regulations. (LD) For tissue establishments located within the United States (U.S.), all living donors, excluding autologous donors, shall be tested and found to be negative for WNV NAT when recovery, collection, or acquisition occurs from June 1 st through October 31 st every year. Ref. D4.231 (R) For tissue establishments located outside the U.S. importing tissues to the U.S., all living donors, excluding autologous donors, shall be tested year-round and found to be negative for WNV NAT. All test results shall be documented in the donor s record. (R) In addition to the infectious disease tests listed above, all anonymous and directed semen and oocyte donors shall undergo testing for Neisseria gonorrhea and Chlamydia trachomatis. The manufacturer s requirements for specimens must be met. If the reproductive tissue is collected by a method that ensures freedom from contamination of the tissue by infectious disease organisms that may be present in the genitourinary tract, then these tests are not required. All anonymous and directed semen donors shall also be tested for total

21 antibody to cytomegalovirus (anti-cmv total, meaning IgG and IgM). Required tests for anonymous and directed embryo donors are listed in D Client depositors who deposit semen, testicular fluid or tissues, oocytes or ovarian tissue, or embryos, shall be tested prior to use for: 1) antibodies to the human immunodeficiency virus, type 1 and type 2 (anti- HIV-1 and anti-hiv-2); 2) hepatitis B surface antigen (HBsAg); and 3) antibodies to hepatitis C virus (anti-hcv). As amended D4.230 Required Infectious Disease Tests Excluding autologous, embryo donor, and client depositor tissue, all human tissue intended for transplantation shall be from donors who are tested and found to be negative for: 1) antibodies to the human immunodeficiency virus, type 1 and type 2 (anti- HIV-1 and anti-hiv-2); 2) nucleic acid test (NAT) for HIV-1; 3) hepatitis B surface antigen (HBsAg); 4) nucleic acid test (NAT) for the hepatitis B virus (HBV); 5) total antibodies to hepatitis B core antigen (anti-hbc total, meaning IgG and IgM); 6) antibodies to the hepatitis C virus (anti-hcv); 7) nucleic acid test (NAT) for HCV; and 8) syphilis (a non-treponemal or treponemal-specific assay may be performed). Donors of viable leukocyte-rich tissue (e.g., semen, certain (CT)) shall also be tested and found to be negative for antibodies to human T-lymphotropic virus type I and type II (anti-htlv-i and anti-htlv-ii). Note: HTLV testing of donors of other tissue types may be required by law and/or regulation, including, where applicable, foreign laws and/or regulations. (LD) For tissue establishments located within the United States (U.S.), all living donors, excluding autologous donors, shall be tested and found to be negative for WNV NAT when recovery, collection, or acquisition occurs from June 1 st through October 31 st every year. Ref. D4.231 (R)